Trial Outcomes & Findings for LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma (NCT NCT03361306)
NCT ID: NCT03361306
Last Updated: 2026-03-06
Results Overview
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
From enrollment to the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
KRd-Elotuzumab
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
KRd-Elotuzumab
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Overall Study
Death
|
6
|
Baseline Characteristics
LCI-HEM-MYE-CRD-002: Carfilzomib-Revlimid-Dexamethasone-Elotuzumab in Relapsed/Refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=41 Participants
|
|
Age, Continuous
|
64 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=41 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=41 Participants
|
|
ECOG at Baseline
0
|
6 Participants
n=41 Participants
|
|
ECOG at Baseline
1
|
8 Participants
n=41 Participants
|
|
ECOG at Baseline
2
|
1 Participants
n=41 Participants
|
|
Baseline ISS Stage
Stage I
|
7 Participants
n=41 Participants
|
|
Baseline ISS Stage
Stage II
|
3 Participants
n=41 Participants
|
|
Baseline ISS Stage
Stage III
|
5 Participants
n=41 Participants
|
|
Baseline R-ISS Stage
Stage I
|
5 Participants
n=41 Participants
|
|
Baseline R-ISS Stage
Stage II
|
5 Participants
n=41 Participants
|
|
Baseline R-ISS Stage
Stage III
|
5 Participants
n=41 Participants
|
|
Prior Lenalidomide Exposure
Prior lenalidomide
|
13 Participants
n=41 Participants
|
|
Prior Lenalidomide Exposure
No prior lenalidomide
|
2 Participants
n=41 Participants
|
|
Prior Bortezomib Exposure
Prior Bortezomib
|
14 Participants
n=41 Participants
|
|
Prior Bortezomib Exposure
No Prior Bortezomib
|
1 Participants
n=41 Participants
|
|
Prior ASCT
Prior ASCT
|
12 Participants
n=41 Participants
|
|
Prior ASCT
No Prior ASCT
|
3 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: From enrollment to the disease response determined at the end of the induction part of regimen (4 cycles of KRd-Elo was planned, but some subjects progressed before the end of induction). The median length of induction was 16 weeks.Population: The response evaluable population is defined as all subjects who initiate treatment with elotuzumab and who have measurable disease at baseline.
The primary endpoint is a binary variable determined for each subject indicating whether the subject achieved a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) to induction treatment with KRd-Elo, as defined by the IMWG 2016 response criteria. Per IMWG 2016 criteria, VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Number of Participants With VGPR or Better Response to Induction
|
6 Participants
|
SECONDARY outcome
Timeframe: From enrollment to best response while on study treatment; subjects remained on treatment until disease progression or death or unacceptable toxicity. Subjects were on treatment for a median of 12 months.Population: The response evaluable population is defined as all subjects who initiate treatment with elotuzumab and who have measurable disease at baseline.
Objective response was determined for each subject as a binary variable indicating whether the subject achieved a best overall response of partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) at any time on study treatment as determined by IMWG 2016 response criteria. Per IMWG 2016 criteria, PR is defined as at least 50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by 90% or to \<200 mg/24h. VGPR is defined as serum/urine M-protein detectable by immunofixation but not electrophoresis OR \>= 90% reduction in serum M protein plus urine M-protein \<100 mg/24 h. CR is defined as negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and \<5% plasma cells in bone marrow aspirates. sCR is defined as CR plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry.
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Number of Subjects With an Objective Response
|
12 Participants
|
SECONDARY outcome
Timeframe: From date of treatment start to date of death, or censored as described; assessed for approximately 5 years.Population: The analysis population consisted of all subjects who initiated Elo-KRd
OS is defined as the duration from treatment start date to the date of death from any cause. Subjects who are alive or lost to follow up at the time of the analysis will be censored at the last known date they were alive.
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Overall Survival (OS)
|
NA months
Interval 10.1 to
Median and upper limit of confidence interval are not reached due to censoring rate
|
SECONDARY outcome
Timeframe: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.Population: The evaluable population consisted of all subjects who initiated Elo-KRd
PFS is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If subject died without documented PD, progression date will be death date. For surviving subjects who do not have PD, PFS will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, PFS will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial PFS event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Progression Free Survival (PFS)
|
10.9 months
Interval 1.9 to 17.1
|
SECONDARY outcome
Timeframe: From treatment start date to date of progression/death, or censored as described; assessed for approximately 3 years.Population: The evaluable population consisted of all subjects who initiated Elo-KRd
TTP is defined as the duration of time from treatment start date to first occurrence of either progressive disease (PD) or death related to disease progression. PD must be objectively determined per IMWG 2016 criteria, where progression date is date of last assessment that identified PD. If a subject died for causes related to disease progression then progression date will be date of death. If a subject died for causes other than disease progression, TTP will be censored at the date of other cause mortality. For surviving subjects who do not have PD, TTP will be censored at the date of last disease assessment. For subjects who received subsequent anti-cancer therapy prior to documented PD, TTP will be censored at the date of last disease assessment prior to commencement of subsequent therapy. Subjects who have an initial TTP event immediately following 2 or more consecutive missed assessments will be censored at date of last assessment prior to missed assessments.
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Time to Disease Progression (TTP)
|
10.9 months
Interval 1.9 to 17.1
|
SECONDARY outcome
Timeframe: From time of first response to date of progression/death, or censored as described; assessed for approximately 3 years.Population: The analysis population consisted of all subjects who initiated Elo-KRd and achieved a PR or better during study treatment.
DoR will be calculated for each subject with a partial response, very good partial response, complete response, or stringent complete response on study treatment. The DoR intervals will be calculated from the time of the first assessment that identified response until disease progression or death. The censoring mechanism for DoR will be the same as described for PFS.
Outcome measures
| Measure |
KRd-Elotuzumab
n=12 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Duration of Response (DoR)
|
13.3 months
Interval 1.8 to 33.0
|
SECONDARY outcome
Timeframe: From treatment start date to date of next treatment, or censored as described; assessed for approximately 3 years.Population: The analysis population consisted of all subjects who initiated Elo-KRd.
TTNT will be calculated from the time of treatment start until the start of the first subsequent anti-cancer therapy after all protocol directed therapy is completed. For surviving subjects who do not receiving subsequent therapy, TTNT will be censored at the last contact date. For subjects who die before beginning subsequent anti-cancer therapy, TTNT will be censored at the date of death
Outcome measures
| Measure |
KRd-Elotuzumab
n=15 Participants
Induction (4 28-day cycles):
Carfilzomib (IV) @ 20 mg/m\^2, Day 1 of Cycle 1; @ 56 mg/m\^2, Day 8,15 of Cycle 1; @ 56 mg/m\^2, Day 1,8,15 of Cycles 2-4
Lenalidomide (Oral) @ 25 mg, once daily at bedtime on Days 1-21 of each cycle (Cycles 1-4)
Dexamethasone @ 28 mg orally OR 8 mg IV, once weekly on Day 1,8,15,22 of Cycles 1-2; @28 mg orally OR 8 mg IV on Day 1 of Cycles 3-4
Elotuzumab (IV) @ 10 mg/kg, once weekly on Day 1,8,15,22 of Cycles 1-2; @ 20 mg/kg on Day 1 of Cycles 3-4
Maintenance (28-day cycles):
Elotuzumab (IV) @ 20 mg/kg, Day 1 of each cycle (Cycles 1-n)
Lenalidomide (Oral) @ 15 mg (or last tolerated dose if \<15 mg), once daily at bedtime on Days 1-21 of each cycle (Cycles 1-n)
|
|---|---|
|
Time to Next Treatment (TTNT)
|
12.1 months
Interval 3.2 to 20.2
|
Adverse Events
KRd-Elotuzumab
Serious events: 8 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
KRd-Elotuzumab
n=15 participants at risk
Carfilzomib, Revlimid, Dexamethasone, Elotuzumab
Elotuzumab: Experimental
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Aortic valve disease
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Death NOS
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Fever
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Upper respiratory infection
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Confusion
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Hematoma
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Thromboembolic event
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
Other adverse events
| Measure |
KRd-Elotuzumab
n=15 participants at risk
Carfilzomib, Revlimid, Dexamethasone, Elotuzumab
Elotuzumab: Experimental
|
|---|---|
|
General disorders and administration site conditions
Chills
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Aortic valve disease
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Atrial fibrillation
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Cardiac disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Chest pain - cardiac
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Palpitations
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Endocrine disorders
Endocrine disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Eye disorders
Blurred vision
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Eye disorders
Eye disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Eye disorders
Floaters
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
6/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
10/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Fecal incontinence
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Flatulence
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Mucositis oral
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Toothache
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Edema limbs
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Fatigue
|
60.0%
9/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Fever
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Infusion related reaction
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Non-cardiac chest pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
General disorders and administration site conditions
Pain
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Bronchial infection
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Infections and infestations - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Rash pustular
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Sinusitis
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Infections and infestations
Upper respiratory infection
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Injury, poisoning and procedural complications
Aortic injury
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Injury, poisoning and procedural complications
Fracture
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Alanine aminotransferase increased
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Aspartate aminotransferase increased
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Blood bilirubin increased
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Cholesterol high
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Creatinine increased
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Investigations - Other, specify
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Lymphocyte count decreased
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Neutrophil count decreased
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Investigations
Platelet count decreased
|
26.7%
4/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Anorexia
|
26.7%
4/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
53.3%
8/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
60.0%
9/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
40.0%
6/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Dysesthesia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Dysgeusia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Headache
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Paresthesia
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Nervous system disorders
Sinus pain
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Agitation
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Insomnia
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Libido decreased
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Psychiatric disorders
Restlessness
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Acute kidney injury
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Renal and urinary disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Urinary incontinence
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Urinary retention
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Renal and urinary disorders
Urine discoloration
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
60.0%
9/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
40.0%
6/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
46.7%
7/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
26.7%
4/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
26.7%
4/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Flushing
|
33.3%
5/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Hematoma
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Hypotension
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Phlebitis
|
6.7%
1/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
|
Vascular disorders
Thromboembolic event
|
13.3%
2/15 • Baseline, during treatment, and through 30 days after study treatment is discontinued, an average of 14 months.
|
Additional Information
Chair of Biostatistics Department
Levine Cancer Institute
Phone: 9804422371
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place